Fecal incontinence is described as the loss of the normal control of the bowels. This leads to stool leaking from the rectum at unexpected times. Fecal incontinence typically is a source of physical discomfort and the cause of social and personal debilitation. It most often affects the aged or individuals suffering from neurological, obstetrical, or other traumatic injury. However, abnormalities in stool volume or consistency, colonic transit, anal sphincter function, anal rectal sensation, cerebral function and anal rectal reflexes also may result in incontinence. A significant number of incontinence cases involve postpartum pelvic neuropathies, and thus, may affect women at a relatively young age.
There may be many causes of fecal incontinence. Fecal continence is multi-faceted. Anal sphincter resting and squeeze pressure, rectal storage capacity, anal and rectal sensation, spinal reflexes, cognition, and anorectal angle all play a role. The anal sphincter is a muscle that contracts to prevent stool from leaving the rectum. That muscle is critical in maintaining continence. The rectum can stretch and hold stool for some time after a person becomes aware that stool is there. That is the rectal storage capacity. Rectal sensation tells a person that stool is in the rectum. Then, the person knows that it is time to go to the bathroom. A person also must be alert enough to notice the rectal sensation and do something about it. He or she must be able to move to a toilet. If something is wrong with any of these factors, then fecal incontinence can occur.
Fecal incontinence may also be caused by a reduction in the compliance of the rectum, which shortens the time between the sensation of the stool and the urgent need to have a bowel movement. Surgery or radiation injury can scar and stiffen the rectum. Inflammatory bowel disease can also make the rectum less compliant.
Because loose stool (diarrhea) is more difficult to control than formed stool, diarrhea is an added stress that can lead to fecal incontinence. A change in stool consistency to a looser form often causes the problem of incontinence to become manifest.
Some cases of fecal incontinence are treated by instituting dietary changes, providing anti-diarrheal agents, fiber exploiting the gastro-colic reflex Not eating prior to attending an important engagement), and effecting “pseudo-continence” by emptying the distal colon and rectum with enemas prior to social events. Biofeedback therapies also have been proposed in which a balloon, inserted in the rectum, provides a sensation similar to that of stool immediately prior to defecating. The patient is trained to perceive differing volumes of distention in the balloon and to respond accordingly by contracting the anal sphincter muscles.
Surgical remedies for severe cases of fecal incontinence include sphincter repair, plication of the posterior sphincter, anal encirclement in which a metal or elastic band mechanically tightens the anus, and muscle transfer procedures. Each of those techniques attempts to create a mechanical barrier to stool. Anal sphincter repair may produce good results, but it is appropriate for women with obstetric injuries to the anal sphincter, and may be effective to a lesser extent for those with other traumatic sphincter injuries. Those patients, though not target subjects for the present invention, could benefit from this invention if surgery is unsuccessful due to concomitant pudendal nerve injury, or if they are poor operative candidates because of their generally poor health, or if they do not want to submit to an invasive procedure. Other surgical procedures typically produce suboptimal results because of persistent leakage of stool, infection and fecal impaction.
Temple, U.S. Pat. No. 5,421,827, discloses an incontinence device that includes a generally tubular soft latex shape that is opened at both ends. The upper end is smoothly curved and tapered inward to the opening with latex of minimal thickness and coated on the outside adjacent the opening with a suitable adhesive for contact with the skin about the anal opening. However, the device is invasive, blocks the anal opening and collects fecal matter and gases in the tubular shape provided.
Klingenstein, U.S. Pat. No. 6,096,057, discloses a fecal incontinence device and method that includes an expandable tubular member that invasively is inserted into the rectum of a patient. The tubular member has attached thereto a pair of bilaterally extending wings which may be detachable that conform to the surface of the buttocks of a patient, thereby maintaining the position of the device in the rectum. A sheath is expanded so as to prevent passage of stool through the anal opening, but cannot be expanded to such an extent as to trigger a defecation reflex.
A problem with such non-surgical devices for controlling fecal incontinence is that they are intrusive or invasive. Accordingly, there is a need in the art for a means for controlling fecal incontinence that is convenient and non-invasive.